This invention relates to a sterile connecting device to provide fluid communication with the sterile contents of a container. More particularly, this invention relates to a piercing pin device having a sheath which will break away from the piercing pin upon contact with and penetration through a pierceable diaphragm forming a part of a container closure.
Piercing members with sheaths of the type concerned with in this invention are disclosed in U.S. Pat. Nos. 2,689,564 and 2,847,995. However, the sheaths surrounding the piercing needles in these patents have the disadvantage of not being fully and uniformly collapsible of slidable along the hub of the needle so as to afford accurate and sterile penetration. Neither does the prior art illustrate the utilization of a slidable or collapsible sheath over the hub of a piercing pin during penetration of a closure diaphragm in conjunction with a closure system which has two spaced-apart diaphragm members to reduce the risk of any contamination during connection with the piercing pin. In U.S. Pat. No. 3,606,077, a guide for a piercing pin is shown in conjunction with a pierceable diaphragm. However, this particular patent is not concerned with a guide for a piercing pin having a break-away and uniformly removable sheath as is disclosed herein. There is not presently available a sterile connecting system which will substantially reduce the risks of contamination frequently attributed to poor technique by the fluid administrator.
It is an advantage of the present invention to afford a sterile connecting device for use in conjunction with a sterile container. Other advantages are a sterile connecting pin having a sheath which will break away from the piercing pin in a substantially symmetrical manner and will uniformly surround the hub of the piercing pin; a piercing member with a break-away sheath which is especially suited for piercing through a double diaphragm structure in a container closure; and a break-away sheath for a piercing pin which will be retained in the container closure.